(19)
(11) EP 1 991 167 B1

(12) EUROPEAN PATENT SPECIFICATION

(45) Mention of the grant of the patent:
12.05.2010 Bulletin 2010/19

(21) Application number: 07751210.1

(22) Date of filing: 20.02.2007
(51) International Patent Classification (IPC): 
A61F 2/16(2006.01)
(86) International application number:
PCT/US2007/004436
(87) International publication number:
WO 2007/098173 (30.08.2007 Gazette 2007/35)

(54)

FLOATING OPTIC ACCOMMODATING INTRAOCULAR LENS

AKKOMMODIERENDE INTRAOKULARLINSE MIT SCHWIMMENDER OPTIK

LENTILLE INTRA-OCULAIRE À ACCOMMODATION OPTIQUE FLOTTANTE


(84) Designated Contracting States:
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

(30) Priority: 21.02.2006 US 360019

(43) Date of publication of application:
19.11.2008 Bulletin 2008/47

(73) Proprietor: C&C Vision International Limited
Dublin 2 (IE)

(72) Inventors:
  • CUMMING, J. Stuart
    Aliso Viejo, CA 92656 (US)
  • DELL, Steven, J.
    Austin, TX 78746 (US)
  • SOISETH, Jonathan, R.
    Pomona, CA 91768 (US)

(74) Representative: Walcher, Armin 
Louis, Pöhlau, Lohrentz Postfach 3055
90014 Nürnberg
90014 Nürnberg (DE)


(56) References cited: : 
EP-A- 1 543 799
US-A1- 2003 109 926
US-A1- 2004 111 152
WO-A1-2006/033984
US-A1- 2004 082 994
US-A1- 2006 020 339
   
       
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND



    [0001] Intraocular lenses have for many years had a design of a single optic with loops attached to the optic to center the lens and fixate it in the empty capsular bag of the human eye. In the mid '80s plate lenses were introduced, which comprised a silicone lens, 10.5 mm. in length, with a 6 mm. optic. These lenses could be folded but did not fixate well in the capsular bag, but resided in pockets between the anterior and posterior capsules. The first foldable lenses were all made of silicone. In the mid 1990s an acrylic material was introduced as the optic of lenses. The acrylic lens comprised a biconvex optic with a straight edge into which were inserted loops to center the lens in the eye and fixate it within the capsular bag.

    [0002] Recently accommodating intraocular lenses have been introduced to the market, which generally are modified plate haptic lenses and, like the silicone plate haptic lenses, have no clear demarcation between the junction of the plate with the optic's posterior surface. A plate haptic lens may be defined as an intraocular lens having two or more plate haptics where combined junctions with the optic represent one quarter or more of the circumference of the optic.

    [0003] Flexible acrylic material has gained significant popularity among ophthalmic surgeons. In 2003 for example more than 50% of the intraocular lenses implanted had acrylic optics. Hydrogel lenses have also been introduced. Both the acrylic and hydrogel materials are incapable of multiple flexions without fracturing.

    [0004] The advent of an accommodating lens which functions by moving the optic along the axis of the eye by repeated flexions somewhat limited the materials from which the lens could be made. Silicone is the ideal material, since it is flexible and can be bent probably several million times without showing any damage. Additionally a groove or hinge can be placed across the plate adjacent to the optic as part of the lens design to facilitate movement of the optic relative to the outer ends of the haptics. An example accommodating lens of this nature is disclosed in U.S. Patent 6,387,126 in the name of J. Stuart Cumming.

    SUMMARY OF THE INVENTION



    [0005] According to the present invention a new form of accommodating intraocular lens having a lens body and optic is provided which can be thought of as including a "floating piston optic" with plural straps or fingers, such as four, between the lens body and optic to allow the optic to move anteriorly and posteriorly in a piston fashion in response to the pressure gradient created with accommodation.

    [0006] Thus, it is a feature of the present invention to provide a new form of accommodating lens.

    [0007] The document US2004082994A1 constitutes the preamble of claim 1. The new form of accommodating intraocular lens of the invention has all features of claim 1.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0008] Figure 1 is a prospective view of the front or anterior side of the lens according to the present invention.

    [0009] Figure 2 is a plan view of the anterior side.

    [0010] Figure 3 is a plan view of the back or posterior side of the lens.

    [0011] Figure 4 is a side view.

    [0012] Figure 5 is an end view.

    [0013] Figure 6 is a cross-sectional view along lines 6-6 of Figure 2.

    [0014] Figure 7 is a perspective view of the back or posterior side of the lens.

    DESCRIPTION OF PREFERRED EMBODIMENT



    [0015] Turning now to the drawings, Figure 1 is a perspective view of the present lens 10 including a lens body or plate 12 and optic 14. The body 12 includes haptics 15. The body 12 and optic 14 are formed of silicone or other suitable flexible material. Flexible straps 16 are provided between the body 12 and the periphery or outer diameter of the optic 14. The straps may be 0.5 mm long in the radial direction and 0.1 mm thick so as to essentially create an "piston optic" 14 supported by the straps. In yet another iteration the lens may have a continuous skirt surrounding the optic and connecting the optic to the lens body. The optic 14 typically can have a diameter of 4.5 mm, a typical width of the overall lens 10 on the short side is 6.1 mm and the typical length from end to end (not including fixation fingers) on the long side is 10.5 mm.

    [0016] The body 12 and optic 14, as well as outer thickened footplate ends 20, are formed of silicone or other suitable flexible material. The lens 10 also includes fixation loops 24 of polymide or similar material. A typical outer loop-to-loop length is 11.5 mm. The thickened ends 20 fully engulf the fixation loops 24 in the silicone thus to provide a strong matrix to hold the loops 24. There is an additional function of these thickened areas of the plate. They also serve to elevate the anterior capsule of the human lens away from the optic and from the posterior capsule after the cataract has been removed. This may serve to reduce capsular opacification and contraction.

    [0017] The straps 16 function as a pseudo-zonular complex, allowing the optic to move anteriorly and posteriorly. The approximately 0.7 mm wide straps are a point of relative weakness in the plane of the lens body 12 encircling the optic 14, thereby allowing the entire optic 14 to herniate forward (anteriorly) from its far posterior position in a translational forward movement. This feature is enhanced by keeping the mass of the optic 14 to a minimum as described below. This new mechanism may boost the effect of the other features of the lens. Rather than a fluid-filled sac pushing through an aperture as in some prior lenses, the present lens involves a deformable solid optic moving anteriorly and posteriorly through a weak area 16 in the plate or body 12. Hinges 18 on the anterior side of the body 12 hinging the haptics 15 further facilitate movement of the optic with ciliary muscle contraction.

    [0018] Another feature allowing the present lens to accommodate is that the optic 14 can be deformable and constructed with a lower durometer than previously built into any lens. The surrounding plate 12 preferably is made of a higher, standard durometer material, similar to the eyeonics Inc. AT45 lens (which is durometer 48). The optic 14 itself is not required to contribute to the structural stability of the lens and, therefore, the optic 14 can be extremely soft. In addition to forward axial translation, the bending or deformation of the optic 14 with accommodation will induce power change. This may result in the bending of the optic to be accentuated. This feature is further enhanced by maintaining the optic very thin since a thinner optic will bend more than a thick optic for any given level of force applied. An example range of optic 14 center thicknesses is about 0.38 mm to 1.07 mm for a diopter range of 10 to 33. A typical common diopter of the optic of the present lens is 22 diopters and which has a thickness of 0.73 mm. As a comparison, the AT 45 noted earlier in a 22 diopter has a thickness of 0.88 mm, and a newer AT-45SE is 0.98 mm.

    [0019] A 4.5 mm diameter optic 14 and with a reduced edge thickness of 0.1 to 0.2 mm for example can be provided. The index of refraction can be increased and this will accentuate this feature even further. The fact that this optic 14 is symmetrically tethered to the plate 12 in all meridians by the straps can mean that power changes in the curvature are also symmetrical, meaning spherical power change as opposed to astigmatic changes found in some other lenses. Optic flexure is a new and poorly understood phenomenon, and unwanted optical distortion may be encountered resulting in poor vision either at near or far distances, in which case the durometer of the material will need to be raised.

    [0020] The present lens can be easily foldable with forceps or an injector. A preloaded system is preferable.

    [0021] An additional feature is the incorporation of a ridge or ridges 40 on the back surface (posterior side) of the plate 12 and/or haptic arm as the case may be as seen in Figs. 3 and 7. These ridges traverse the plate and completely encircle the optic around the perimeter of the lens body. There is an additional ridge central to the first ridge traversing the plate adjacent to the optic straps. The purpose of these ridges is to prevent proliferation of lens epithelial cells into the area behind the plate or optic. For plate lenses this can dramatically reduce the incidence of capsular contraction. Epithelial cells will be prevented from migrating under the plate and undergoing a fibrotic contraction. Furthermore, the square edge of the loops, plate haptics and the square edge of the optic further protect against cells migrating in from the sides of the plate.

    [0022] While an embodiment of the present invention as been shown and described, various modifications may be made without departing from the scope of the present invention.


    Claims

    1. An accommodating intraocular lens (10) comprising a flexible body evenly spaced from and surrounding a flexible optic, the flexible optic (14) being mounted to the body (12) by a plurality of thin flexible straps (16) disposed between the optic and the body, characterised by the straps being approximately 0.5 mm long radially and approximately 0.1 mm thick, and the lens including a plurality of fixation loops (24) attached to ends of the body.
     
    2. A lens as in Claim 1 including haptics (15) with a weakened thinned or hinged (16) portion within the lens body for allowing the lens optic and its surrounding body cental to the higes to move forward and backward relative to the outer ends of the haptics.
     
    3. A lens as in Claim 1 wherein the outer ends of the lens body include loops (24) to securely fixate and center the lens.
     
    4. A lens as in Claim 1 wherein the optic is constructed to optically deform, with ciliary muscle contraction, to enhance near vision.
     
    5. A lens as in Claim 1 wherein the lens body has anterior projections (18) to separate the anterior human lens capsule from the lens body, thereby creating a space for the optic to move forward upon ciliary muscle contraction.
     


    Ansprüche

    1. Akkommodierende Intraokularlinse (10), umfassend einen flexiblen Körper, der in gleichmäßigem Abstand von einer flexiblen Optik angeordnet ist und diese umgibt, wobei die flexible Optik (14) am Körper (12) durch eine Mehrzahl von dünnen, flexiblen Stegen (16), die zwischen der Optik und dem Körper angeordnet sind, montiert ist, dadurch gekennzeichnet, dass die Stege eine Länge von etwa 0,5 mm in radialer Richtung und eine Dicke von etwa 0,1 mm aufweisen und die Linse eine Mehrzahl von Befestigungsschlingen (24), die an den Enden des Körpers angebracht sind, umfasst.
     
    2. Linse nach Anspruch 1, umfassend Haptiken (15) mit einem geschwächten, verdünnten oder angelenkten (16) Bereich innerhalb des Linsenkörpers, um der Linsenoptik und ihrem zentral zu den Gelenken angeordneten, umgebenden Körper eine Vorwärts- und Rückwärtsbewegung relativ zu den äußeren Enden der Haptiken zu ermöglichen.
     
    3. Linse nach Anspruch 1, wobei die äußeren Enden des Linsenkörpers Schlingen (24) umfassen, um die Linse sicher zu fixieren und zu zentrieren.
     
    4. Linse nach Anspruch 1, wobei die Optik so aufgebaut ist, dass sie sich optisch mit der Kontraktion des ziliarmuskels deformiert, um die Nahsicht zu verstärken.
     
    5. Linse nach Anspruch 1, wobei der Linsenkörper vordere Vorsprünge (18) aufweist, um die vordere humane Linsenkapsel vom Linsenkörper zu trennen, wodurch ein Zwischenraum für die Optik geschaffen wird, um sich bei Kontraktion des Ziliarmuskels nach vorne zu bewegen.
     


    Revendications

    1. Lentille intraoculaire à accommodation (10) comprenant un corps souple régulièrement espacé d'une optique souple et entourant celle-ci, l'optique (14) souple étant montée sur le corps (12) par une pluralité de minces bandes (16) souples disposées entre l'optique et le corps, caractérisée en ce que les bandes ont une longueur d'environ 0,5 mm radialement et une épaisseur d'environ 0,1 mm, et la lentille comprend une pluralité de boucles de fixation (24) fixées aux extrémités du corps.
     
    2. Lentille selon la revendication 1, comprenant des parties haptiques (15) avec une partie amincie fragilisée ou articulée (16) dans le corps de lentille pour permettre à l'optique de lentille et à son corps environnant au centre des articulations de se déplacer vers l'avant et vers l'arrière par rapport aux extrémités externes des parties haptiques.
     
    3. Lentille selon la revendication 1, dans laquelle les extrémités externes du corps de lentille comprennent des boucles (24) pour bien fixer et centrer la lentille.
     
    4. Lentille selon la revendication 1, dans laquelle l'optique est réalisée de manière à se déformer optiquement, avec la contraction du muscle ciliaire, pour améliorer la vision de près.
     
    5. Lentille selon la revendication 1, dans laquelle le corps de lentille comporte des protubérances antérieures (18) pour séparer la cristalloïde humaine antérieure du corps de lentille, créant de ce fait un espace pour que l'optique se déplace vers l'avant lors de la contraction du muscle ciliaire.
     




    Drawing











    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description